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RECRUITING
NCT06061614
EARLY_PHASE1

Safety and Efficacy Study of NGGT002 in PKU Adult Subjects

Sponsor: The First Affiliated Hospital of Bengbu Medical University

View on ClinicalTrials.gov

Summary

This is a single-center, open-label, non-randomized, dose escalation study to evaluate the safety, tolerability and efficacy of NGGT002 in adult Phenylketonuria (PKU) subjects. All subjects will receive a single administration of NGGT002 and will be followed for safety and efficacy for 5 years.

Official title: A Clinical Study for the Safety and Efficacy of IV Infusion of NGGT002 in the Treatment of Phenylketonuria

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2023-03-30

Completion Date

2028-12-30

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

GENETIC

NGGT002 Injection

Dose escalation will proceed sequentially from Dose Level 1 to Dose Level 5 in a single-dose administration of NGGT002.

Locations (1)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China